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临床试验/NCT01998295
NCT01998295已完成4 期

Parasite Clearance Time and Time to Recurrent Infection Following Treatment With Artemether/Lumefantrine Among Children With Uncomplicated P. Falciparum Malaria Five Years After Wide Scale Use of the Drug in Tanzania

Muhimbili University of Health and Allied Sciences1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
45
试验地点
1
主要终点
Time to parasite clearance

研究概览

简要总结

Plasmodium falciparum resistance against artemisinins has been confirmed in South-East Asia and it is expressed phenotypically as a slow rate of parasite clearance. Nonetheless, it is not known whether the problem exist in Tanzania. This study assessed parasite clearance time and time to recurrent infection following treatment with Artemether/Lumefantrine (AL) among children with uncomplicated malaria.

详细描述

Artemether/Lumefantrine (AL) has been in wide scale use in Tanzania since 2007 as first line treatment for uncomplicated falciparum malaria. Nonetheless, reports of confirmed resistance against Artemisinin derivatives expressed phenotypically as prolonged parasite clearance have emerged from South-East Asia (SEA), signifying reduced parasites susceptibility to the otherwise rapidly acting artemisinins. Prolonged clearance is associated with an increase in day 28 treatment failure, gametocytes carriage and transmission of resistance. Nonetheless, no detailed study has been done in East Africa to assess parasite clearance time following treatment with Artemisinin based combination therapies (ACTs).

In order to evaluate time to parasite clearance following treatment with AL, we conducted a detailed clinical trial with twenty blood sampling time points prior, during and after treatment. Detailed sampling allowed us to assess parasite clearance, and selection of Plasmodium falciparum multidrug resistance (Pfmdr) 1 N86Y and Plasmodium falciparum chloroquine resistance transporter (Pfcrt) K76T genes between different time points and its association with parasite clearance and recurrence. Furthermore, as a sensitive tool and an ideal early warning system, nested polymerase chain reaction (PCR) was used to assess parasite clearance and compare it with microscopic findings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 120 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age 6-120 months
  • Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL
  • No general danger signs or severe malaria present
  • Hemoglobin ≥5 g/dL
  • History of fever within 24 hours or axillary temperature ≥ 37.5 degree Celsius
  • No other cause of fever is detectable
  • No severe malnutrition
  • Guardian/patient has consented

排除标准

  • general danger signs or signs of severe falciparum malaria
  • severe malnutrition
  • febrile condition due to diseases other than malaria
  • regular medication which might interfere with antimalarial pharmacokinetics
  • contraindications to any medicine being used

研究组 & 干预措施

Artemether/lumefantrine

Active Comparator

Artemether/lumefantrine tablets, 6 doses, for 3 days

Dosage:

  1. tablet for body weight between 5-14.9 Kilograms.
  2. tablets for body weight between 15-24.9 Kilograms.
  3. tablets for body weight between 25-34.9 Kilograms.

干预措施: Artemether/lumefantrine (Drug)

结局指标

主要结局

Time to parasite clearance

时间窗: 72 hours

Time to parasite clearance was assessed by taking blood samples and examining it by light microscopy prior (0 hour) and during treatment at 4, 8, 12 hours and then 6 hourly until two consecutive negative blood slides.

次要结局

  • Time to recurrent infection(42 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Mwaiswelo

Investigator

Muhimbili University of Health and Allied Sciences

研究点 (1)

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